Spinal implant apparatus and methods

ABSTRACT

A method of inserting and positioning an intervertebral spacer is provided. The spacer includes a longitudinal axis, an on-axis interface coincident with or parallel to the longitudinal axis, and an off-axis interface angled to the longitudinal axis. The spacer&#39;s front end may be curved. The method may include inserting the spacer into the disc space utilizing a tool to engage an on-axis interface and then to engage one or more of the off-axis interfaces, which may be used for further modification of the spacer. The tool is moved substantially along a single insertion direction, which may be substantially parallel to a posterior-anterior axis of the disc space. The method may result in the longitudinal axis of the spacer being perpendicular to the insertion direction, or substantially parallel to a medial-lateral axis of the disc space. The spacer may also be positioned in an anterior aspect of the disc space.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 13/491,944, filed Jun. 8, 2012, which is a continuation of U.S.patent application Ser. No. 12/384,107, now U.S. Pat. No. 8,216,317,filed Mar. 31, 2009, which claims the benefit of U.S. Provisional PatentApplication No. 61/040,821, filed on Mar. 31, 2008, and U.S. ProvisionalPatent Application No. 61/091,505 filed on Aug. 25, 2008, thedisclosures of which are hereby incorporated herein by reference.

BACKGROUND OF THE INVENTION

The present invention relates to a spinal implant apparatus and a methodof using that apparatus to treat a spine disorder. More particularly,the present invention relates to an implant apparatus, which includes asteerable spacer and a manipulation device or positioning tool, and amethod for using the positioning tool to position the spacer at adesirable position at the anterior region of a vertebra. Further, thepresent invention relates to an intervertebral spacer arranged forselectable steerage to a location of interest between adjacentvertebrae, and a mechanism to manipulate or alter the apparatus in anoff-axis manner.

Back pain can be caused by any one of several problems that affect theintervertebral discs of the spine. These problems include, for example,degeneration, bulging, herniation, thinning of a disc, or abnormalmovement, and the pain that is experienced generally is attributable tofriction or pressure that inevitably occurs when one adjacent vertebraexerts uneven pressure, or when both adjacent vertebrae exert suchpressure, on the disc. Back pain may also be attributed to neuralelement injury.

Whenever an individual suffers from a disc problem, a typical remedy isto perform interbody, intervertebral, cervical, thoracic, or lumbarfusion (all generically referred to herein as “IF”) surgery on thepatient for the purpose of fusing together the two vertebrae that flankthe defective disc to form a single, solid bone mass. Existing IFtechniques generally involve removing the offending disc from thepatient, adding bone graft material into the interbody space between theflanking vertebrae, and inserting a spinal implant device into thatspace to hold the graft material in place and to support the flankingvertebrae while solid bone mass forms.

Existing IF techniques fail to enable fine positioning of an implantdevice with respect to the vertebrae. A brief discussion of the basicanatomy of the human spine, and specifically, the lumbar vertebrae ofthe spine, will help better illustrate this limitation. FIG. 1 is apartial representation of the lumbar region of a human spine, in whichan intervertebral disc 10 is arranged between a superior vertebra 20 andan inferior vertebra 30. Specifically, disc 10 is positioned between abottom surface 21 of superior vertebra 20 and a top surface 31 ofinferior vertebra 30. FIG. 2 is a top view of inferior vertebra 30,which includes top surface 31 of a vertebral body 32. Vertebral body 32is formed by a cortical rim 33, which is a dense, hard shell that isformed by compact bone, and an end plate portion 34 formed by muchsofter and less compact end plate material, or cancellous bone.

Referring to FIG. 3, existing IF procedures, including those associatedwith the lumbar region, involve positioning at least one spinal implant50 so that it is substantially centered between end plate portion 34 ofinferior vertebra 30 and an end plate portion 24 on bottom surface 21 ofsuperior vertebra 20. Such positioning of implant 50 does not promotelordosis. Further, in this position, implant 50 tends to depress upon,or even become embedded in, end plate portion 34 of inferior vertebra 30and/or end plate portion 24 of superior vertebra 20. This settling ofimplant 50 is referred to as subsidence, during which thevertebrae-supporting properties of implant 50 are reduced or eliminated.The result may be less than desirable coronal and/or sagittal alignmentof the spine.

Existing IF procedures are further limited in other ways. During IFsurgery, the surgeon must navigate a spinal implant device through aregion that is densely packed with neural elements, muscle, ligaments,tendons and bone to access top surface 31 of inferior vertebra 30. Inexisting IF techniques, this requires extensive cutting and/ormanipulation of this region, which can extend patient recovery time andsubject the patient to other side effects, such as, for example,inflammation, which can be discomforting. Worse, in some patients, thepatient must be entered in two or three of at least three possible bodyareas (i.e., the patient's posterior region in a posterior interbodyfusion technique, the patient's anterior region in an anterior interbodyfusion technique, the patient's lateral region in a lateral interbodyfusion technique, and/or the patient's transforaminal region in atransforaminal interbody fusion technique) for the purpose ofpositioning the spinal implant device. More generally, existing IFtechniques are substantially invasive and can be difficult to perform.

Further, a limitation of existing tools used in IF procedures relates tothe design of the spinal implant device. In some IF procedures, locatingthe spinal implant device in the position of interest cannot be done byhand alone. Instead, a tool is required to push the spinal implantdevice to the position of interest, particularly when lordosis promotionis the goal of the IF procedure. Present spinal implant devices areconfigured so that their interface with the positioning tool occurs onlyalong or parallel to the primary longitudinal axis, one of theorthogonal axes, of the spinal implant device. The primary longitudinalaxis generally coincides with anterior or posterior directions ofinsertion. For example, certain presently used spinal implant devicesare rectangular in shape and include a port that is centrally andparallelly aligned with the primary longitudinal axis of the spinalimplant device used to releasably receive the positioning tool therein.As a result, such a spinal implant device (herein referred to as an“on-axis” spinal implant device) can only be moved and/or guided by thepositioning tool in a straight line along its primary axis. If theon-axis spinal implant device is not initially aligned directly with itsultimate intervertebral location, or if it shifts during travel, it willnot reach its ultimate position of interest without considerable effortand time to ensure that the on-axis spinal implant device is as close tothe position of interest as possible. Even then, the surgeon cangenerally only approximate that position. Therefore, the configurationof current on-axis spinal implant devices limits a surgeon's ability toplace the spinal implant device effectively.

What is needed, therefore, is a spinal implant apparatus and method ofusing the apparatus that enable a surgeon to easily, consistently, andeffectively position a prosthetic intervertebral spacer substantially atthe anterior region of an intervertebral disc space, i.e. between thecortical rims of adjacent vertebrae, with as minimal an impact on thepatient as possible. Such an apparatus would decrease patient risk,speed recovery and substantially improve success rates in terms ofrestoration of normal spinal confirmation and neurologicaldecompression.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide an apparatus fortreating a patient in need of IF surgery. The apparatus specificallyenables a surgeon to position a spacer to a desirable position. Thepresent apparatus is a spacer including one or more off-axis contactsites and, optionally, one or more on-axis contact sites. For purposesof description of the present invention, “off-axis” means a steerage,directional and/or expansion contact location that is anywhere part ofthe spacer except at a location that is aligned with the primarylongitudinal axis of the spacer. An off-axis location may include anynon-orthogonal location, as well as orthogonal locations except for theprimary longitudinal axis of the spacer. The contact sites are arrangedfor releasable interfacing with a steering and/or expansion tool and toenable fine and minimally invasive manipulation within the patient forpositioning the spacer at the desirable location. The spacer includes aprimary rectangular shape but is not limited thereto. In one or moreembodiments, the spacer includes one or more chamfered corners orsections, which may be of rectangular shape. One or more of the one ormore chamfered corners may include a tool interface, such as a portarranged to allow for releasable insertion of a tool insert.Alternatively or additionally, one or more of the one or more chamferedcorners may include a nodule or pin that may be releasably joined to atool interface. The spacer may thusly be configured to enable itssteerage from a starting location to the desirable location at more thanjust straight-line movements using a positioning tool of interest.Instead, the spacer may be moved at 30°, 45°, or any other angles ofinterest with respect to the axis of insertion, including orthogonalangles other than on the primary longitudinal axis of the spacer.

Further, in an embodiment of the spacer including a curved front end,the off-axis interface arrangement enables the surgeon to move thespacer in an arc if that is deemed to be a suitable means of traversal.For example, the spacer front end may be configured in a shape thatcauses it to have a higher frictional characteristic interface with theend plate (or vertebral body surface) while the back end may have alower frictional characteristic at that interface. Such a design enablesa type of sliding motion of the spacer when pushed off-axis. The presentinvention is applicable in any type of spinal surgery. While the focusof the discussion of a preferred embodiment of the present invention isdirected to lumbar IF surgery, it is to be understood that the inventionmay be employed in cervical and thoracic spinal procedures, as well asfrom any direction, i.e., anterior, posterior, and lateral.

In one example, the steerable spacer further includes a plurality ofsurfaces and a plurality of ports that are formed partially within, orentirely through, the plurality of surfaces. The plurality of ports maybe located at selectable positions on one or more surfaces of thespacer, and, preferably, but not essentially, at least two of the portsare located on two surfaces that are at the rear end, and, preferably,but not essentially, at least one of the ports is on a surface that isnot located at the rear end.

The present invention not only provides one or more devices and relatedmethods for off-axis spacer positioning, it also provides for off-axisalteration of the size and/or shape of a spacer, such as with anexpandable spacer (cage), for example. In particular, then, the presentinvention establishes one or more interbody distracting devices andrelated tool usage to enable the off-axis modification or alteration ofthe position, size and/or shape of such interbody distracting devices.The one or more devices may include one or more on-axis features, but doinclude one or more off-axis features.

The present invention is constructed to decrease patient risk, speedrecovery, and substantially improve success rates in terms ofrestoration of normal spinal confirmation and neurologicaldecompression. This is achieved by providing the surgeon with a spacerthat is much more readily movable into an intervertebral position deemedbest suited for the patient's condition and, possibly, altered in size,dimension and/or shape to further improve the implant's clinical result.These and other advantages of the present invention will become apparentupon review of the following description and accompanying drawings.

A first aspect of the present invention is a method of inserting andpositioning a prosthetic intervertebral spacer in the intervertebraldisc space between two adjacent vertebrae comprising the steps ofproviding a spacer including a longitudinal axis, an on-axis interface,and an off-axis interface, the on-axis interface being coincident withor parallel to the longitudinal axis, and the off-axis interface beingangled with respect to the longitudinal axis, engaging a tool to theon-axis interface, inserting the spacer at least partially into theintervertebral disc space by moving the tool substantially along aninsertion direction, engaging the tool to the off-axis interface, andinserting the spacer further into the intervertebral disc space bymoving the tool substantially along the insertion direction, such thatthe longitudinal axis of the spacer is angled with respect to theinsertion direction.

In accordance with certain embodiments of this first aspect, theinsertion direction may be substantially parallel to aposterior-anterior axis of the intervertebral disc space. The method mayfurther include the steps of engaging the tool to a second off-axisinterface of the spacer, and inserting the spacer further into theintervertebral disc space by moving the tool substantially along theinsertion direction. The combination of the inserting steps may resultin the longitudinal axis of the spacer being perpendicular to theinsertion direction. The longitudinal axis of the spacer may besubstantially parallel to a medial-lateral axis of the intervertebraldisc space. The inserting steps may result in the spacer beingpositioned in an anterior aspect of the intervertebral disc space. Theinserting steps may include allowing the spacer to rotate with respectto the insertion direction. The spacer may further include a front endhaving frictional properties that are greater than frictional propertiesof a rear end of the spacer, and the inserting steps may includeallowing the front end to turn within the intervertebral disc space asit frictionally engages one or both of the adjacent vertebrae. Theon-axis and off-axis interfaces may be ports, the tool may include aretractable member, and the engaging steps may include placing theretractable member in the respective ports. The combination of theinserting steps may result in the longitudinal axis of the spacer beingrotated approximately 90 degrees with respect to the insertiondirection. The method may further include the step of packing bonegrafting material into at least one of the on-axis interface, theoff-axis interface, and an opening in the spacer. The method may furtherinclude the step of expanding the spacer.

A second aspect of the present invention is a method of inserting andpositioning a prosthetic intervertebral spacer in the intervertebraldisc space between two adjacent vertebrae comprising the steps ofproviding a spacer including a curved front end, a longitudinal axis, anon-axis interface, and an off-axis interface, wherein the on-axisinterface is coincident with or parallel to the longitudinal axis, andwherein the off-axis interface is angled with respect to thelongitudinal axis, establishing a connection between a tool and thespacer, the connection being at the on-axis interface, inserting thespacer at least partially into the intervertebral disc space by movingthe tool substantially along an insertion direction, relocating theconnection to the off-axis interface, and inserting the spacer furtherinto the intervertebral disc space by moving the tool substantiallyalong the insertion direction, such that the spacer rotates with respectto the insertion direction.

In accordance with certain embodiments of this second aspect, the methodmay further include the steps of engaging the tool to a second off-axisinterface of the spacer, and inserting the spacer further into theintervertebral disc space by moving the tool substantially along theinsertion direction. The combination of the inserting steps may resultin the longitudinal axis of the spacer being perpendicular to theinsertion direction. The inserting steps may result in the spacer beingpositioned in an anterior aspect of the intervertebral disc space. Thespacer may further include a front end having frictional properties thatare greater than frictional properties of a rear end of the spacer, andthe inserting steps may include allowing the front end to turn withinthe intervertebral disc space as it frictionally engages one or both ofthe adjacent vertebrae. The on-axis and off-axis interfaces may beports, the tool may include a retractable member, and the establishingstep may include placing the retractable member in the respective ports.

A third aspect of the present invention is a method of inserting andpositioning a prosthetic intervertebral spacer in the intervertebraldisc space between two adjacent vertebrae comprising the steps ofproviding a spacer including a longitudinal axis, an on-axis interface,and an off-axis interface, the on-axis interface being coincident withor parallel to the longitudinal axis, and the off-axis interface beingangled with respect to the longitudinal axis, applying a first force tothe on-axis interface to move the spacer in the intervertebral discspace, and applying a second force to the off-axis interface to furthermove the spacer in the intervertebral disc space, wherein the first andsecond forces are provided by a tool moving substantially along a singledirection and the first and second forces cause the spacer to rotate.

In accordance with certain embodiments of this third aspect, the spacermay further include a front end having frictional properties that aregreater than frictional properties of a rear end of the spacer, and theapplying steps may include allowing the front end to turn within theintervertebral disc space as it frictionally engages one or both of theadjacent vertebrae.

A fourth aspect of the present invention is a method of inserting andpositioning a prosthetic intervertebral spacer in the intervertebraldisc space between two adjacent vertebrae comprising the steps ofproviding a spacer including a longitudinal axis and an off-axisinterface being angled with respect to the longitudinal axis, providinga tool for use in expanding the spacer, engaging the tool to theoff-axis interface, and expanding the spacer.

A fifth aspect of the present invention is a prosthetic intervertebralspacer comprising a longitudinal axis, an on-axis interface beingcoincident with or parallel to the longitudinal axis, an off-axisinterface being angled with respect to the longitudinal axis, a frontend including a beveled edge, and a rear end having an on-axis chamferedsection being perpendicular to the longitudinal axis and an off-axischamfered section being angled with respect to the longitudinal axis.

In accordance with certain embodiments of this fifth aspect, the frontend may be curved with respect to the longitudinal axis. The on-axisinterface may be disposed on the on-axis chamfered section and theoff-axis interface may be disposed on the off-axis chamfered section.The front end may have frictional properties and the rear end may havefrictional properties, the frictional properties of the front end beinggreater than the frictional properties of the rear end.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of a partial spinal arrangement of anintervertebral disc and two vertebrae.

FIG. 2 is a top view of the inferior vertebra of FIG. 1.

FIG. 3 is a side view similar to FIG. 1 showing an existing spinalimplant device positioned between the end plate portions of the inferiorand superior vertebrae.

FIG. 4 is a perspective view of an apparatus of the present inventionincluding a spacer and a positioning tool removably connected to thespacer.

FIG. 5 is a side view similar to FIG. 1 showing a spacer of the presentinvention positioned near the anterior regions and substantially betweenthe cortical rims of inferior and superior vertebrae.

FIG. 6 is a first side view of the spacer of FIG. 4.

FIG. 7 is a second side view of the spacer of FIG. 4.

FIG. 8 is a partial cross-sectional top view of a rear end of the spacerof FIG. 4.

FIG. 9 is a side view of a portion of the positioning tool of FIG. 4.

FIG. 10 is a front view of the positioning tool of FIG. 4.

FIG. 11 is a flow diagram of the steps of a method of inserting a spaceraccording to the present invention.

FIGS. 12-14 are top perspective views depicting a method of insertingand positioning the spacer according to the present invention.

FIG. 15 is a top perspective view of the spacer positioned in adesirable location according to the method depicted in FIGS. 12-14.

FIG. 16 is a top view of another embodiment of a spacer of the presentinvention, the bottom being a mirror image thereof.

FIG. 17 is a first side view of the spacer of FIG. 16, the second sidebeing a mirror image thereof.

FIG. 18 is a rear view of the spacer of FIG. 16, the front being amirror image thereof.

FIG. 19 is a top view of another embodiment of a spacer of the presentinvention, the bottom being a mirror image thereof.

FIG. 20 is a first side view of the spacer of FIG. 19, the second sidebeing a mirror image thereof.

FIG. 21 is a rear view of the spacer of FIG. 19.

FIG. 22 is front view of the spacer of FIG. 19.

FIG. 23 is top view of another embodiment of a spacer of the presentinvention, the bottom being a mirror image thereof.

FIG. 24 is a first side view of the spacer of FIG. 23.

FIG. 25 is a rear view of the spacer of FIG. 23.

FIG. 26 is a front view of the spacer of FIG. 23.

FIG. 27 is a top view of another embodiment of a spacer of the presentinvention, the bottom being a mirror image thereof.

FIG. 28 is a first side view of the spacer of FIG. 27, the second sidebeing a mirror image thereof.

FIG. 29 is a rear view of the spacer of FIG. 27.

FIG. 30 is a top view of an expandable embodiment of a spacer of thepresent invention in an unexpanded configuration, the bottom being amirror image thereof.

FIG. 31 is a second side view of the expandable spacer of FIG. 30 in anunexpanded configuration, the first side being a mirror image thereof.

FIG. 32 is a rear view of the expandable spacer of FIG. 30.

FIG. 33 is second side view of the expandable spacer of FIG. 30 in anexpanded configuration, the first side being a mirror image thereof.

DETAILED DESCRIPTION

Referring to FIG. 4, a spinal implant apparatus 90 of the presentinvention includes a prosthetic intervertebral spacer 100 and apositioning tool 200 for fine and minimally invasive manipulation ofspacer 100 within a patient in need of lumbar interbody fusion (“LIF”)surgery. Apparatus 90 allows spacer 100 to be easily and consistentlypositioned to a desirable location 36 as represented in FIG. 5, wheredesirable location 36 is near the anterior region 35 of inferiorvertebra (a similar desirable location located near the anterior regionof superior vertebra 20). Therefore, spacer 100 is shown in FIG. 5 asbeing positioned substantially between the upper surface of cortical rim33 of inferior vertebra 30 and the lower surface of the cortical rim ofsuperior vertebra 20. Positioned in desirable location 36, spacer 100 ismaximally supported by cortical rim 33 (and a like cortical rim ofsuperior vertebra 20), and spacer 100 better promotes alignment andlordosis than it would if it were located substantially adjacent to endplate portion 34 (see FIG. 3) or anywhere else along inferior vertebra30.

Referring to FIGS. 6 and 7, spacer 100 is in a single, integral form. Itis to be understood, however, that spacer 100 is not limited to being ina single, integral form. Therefore, spacer 100 may be formed of aplurality of parts, with any particular part being either removablyconnectable to, or being permanently fixed to, any other particularpart. Further, spacer 100 may be of any selectable shape provided it isconfigured to allow for its forced movement into a selectable positionat desirable location 36. Further, spacer 100 may be expandable to allowthe surgeon to fine tune lordosing adjustment.

Spacer 100 includes a plurality of surfaces, which include a top surface130, a bottom surface 140, a first side surface 110, a second sidesurface 120, a first spacer contact surface 150, and a second spacercontact surface 160. One or more openings 112 are optionally formedthrough top surface 130 and/or bottom surface 140 and may extend fullytherebetween. First spacer contact surface 150 and second spacer contactsurface 160 are at a rear end 103 of spacer 100, spaced opposite from afront end 106 by a body region 108. Each one of second side surface 120,first spacer contact surface 150, and second spacer contact surface 160includes a port 170 (shown as ports 170 a-c in FIG. 8). Port 170 a islocated on first contact surface 150. Port 170 b is located on secondcontact surface 160. Port 170 c is located on second side surface 120.It is to be understood, however, that spacer 100 is not limited tohaving any one or more of ports 170 a, 170 b, or 170 c. Spacer 100 maytherefore include none, one, or two of ports 170 a, 170 b, and 170 c,and it may include one or more additional ports 170 at one or more othersurfaces of spacer 100 that may not necessarily be second side surface120, first spacer contact surface 150, or second spacer contact surface160. Further, referring to FIG. 8, any particular port 170 may be formedas extending partially into spacer 100 (e.g., ports 170 a and 170 bformed within surfaces 150 and 160, respectively) or completely throughspacer 100 from one surface to another (e.g., port 170 c formedcompletely through second side surface 120 and an interior surface 114of opening 112).

Front end 106 and bottom surface 140 of spacer 100 are designedspecifically to enable steerable movement of spacer 100 to desirablelocation 36 when spacer 100 is moved along top surface 31 of inferiorvertebra 30. In the embodiment shown in FIG. 4, front end 106 is ofcurved form, as it is preferably inserted such that the curved portionof front end 106 points toward the medial portion of the intervertebraldisc space. Although shown curved only in its front end, the spaceraccording to the present invention may be curved along one or moreportions or the entirety of the body region of the spacer. Front end 106may be of different dimensions than rear end 103. Front end 106 may alsobe beveled or otherwise shaped to increase its friction with respect totop surface 31 so that it is inclined to dig into the cancellous boneand be forced to turn in a direction associated with the direction ofits curved form. That is, the area at or adjacent to the curved form offront end 106 produces greater friction between inferior vertebra 30 andbottom surface 140 (as shown best in FIG. 7), than is produced betweenthe area at or adjacent to rear end 103 of bottom surface 140 andinferior vertebra 30. Accordingly, the same could be true for topsurface 130 with respect to superior vertebra 20. The increasedfrictional properties may be determined by the height or shape of spacer100 at front end 106 relative to the height of the disc space, or may bedue to roughened or textured surfaces of front end 106 adjacent inferiorvertebra 30 and superior vertebra 20. More specifically, the curvednature of front end 106 or its overall shape may provide or supplementthe frictional aspects of front end 106. Other known methods may also beused to increase the friction to a desired level. The increasedfrictional properties of spacer 100 at front end 106 are advantageousfor positioning spacer 100 on top surface 31 of inferior vertebra 30, aswill be described with regard to the method of insertion, presentedbelow.

An exemplary positioning tool 200 that may be used for releasablejoining to any of the positioning interfaces described herein, e.g.ports 170, is shown in FIGS. 9 and 10. It is to be understood thatpositioning tool 200 is a generic insertion tool or device, and thatother similar tools or devices may be used. Other devices may beemployed for the purpose of causing movement of any of the spacersdescribed herein. Positioning tool 200 includes a housing member 210, aspacer contact portion 220, and a retractable member 230 that iscontained within, and is movable within, housing member 210. Retractablemember 230 includes a tip 232 that is arranged for securable, butremovable, insertion within any of interface ports 170 of spacer 100, orany other spacer herein described. Retractable member 230 may beflexible, yet of sufficient rigidity to maintain its insertion into port170 while allowing a spacer connected to positioning tool 200 to move orpivot with respect to the longitudinal axis of positioning tool 200.Housing member 210 may include an optional cutaway section 235 forviewing retractable member 230, and therefore for viewing any movementof retractable member 230, within housing member 210. Along these lines,retractable member 230 may be marked with indicia such that the surgeoncan tell of its longitudinal displacement with respect to housing member210. At least a portion of retractable member 230 is extendable beyondan opening 222 of contact surface 220, to a position such as position240, which is outside housing member 210 near contact surface 220. Theskilled artisan will recognize that there are a number of options fordesigning positioning tool 200 such that retractable member 230 iscapable of being moved within, and to a position outside of, housingmember 210. In addition to opening 222, contact portion 220 includes atleast one contact surface 224 for contacting spacer 100.

The skilled artisan will recognize that a spacer and a positioning toolaccording to the present invention may be formed from any one or more ofa plurality of materials. Regardless of the material used to form thespacer, that material or materials should have physical propertiessufficient to allow it to withstand the rigors of being manipulated by apositioning tool during surgery, and to remain intact and in thepreferred position, e.g., desirable location 36, within the harshenvironment that is the human spine. Materials that may be used to formthe spacer and/or the positioning tool include, but are not limited to,non-metallic materials, such as polymer materials, includingpolyetherketone (PEK), polyetherketoneketone (PEKK),polyetheretherketone (PEEK), polyetherketoneetherketoneketone (PEKEKK),or a combination thereof, for example, and metallic materials, such astitanium and alloys including titanium, for example.

A method of insertion according to the present invention may be carriedout for the purpose of treating a patient who is experiencing anintervertebral disc problem, such as degeneration, bulging, herniation,and/or thinning, of a disc of the lumbar region of a spine, for example.The method generally includes steps for using positioning tool 200 toposition spacer 100 substantially between the outer, dense portion of avertebra and the vertebra that is adjacent and superior to thatvertebra, from which an intervertebral disc has been surgically removed.Specifically, the method allows for a 360° fusion of these inferior andsuperior vertebrae with minimal disruption of the surrounding softtissue in, and minimal bone removal from, the patient. Therefore, themethod is minimally invasive. However, it is contemplated that themethod may be carried out as part of a surgery that is not entirelyminimally invasive.

Before any of the steps of the method of insertion are to be carriedout, it is expected that the patient will undergo a plurality ofpreparation steps. These preparation steps may include, but are notlimited to being, those steps that are generally taken by those skilledin the art of performing a standard unilateral or bilateraldecompressive laminectomy. These steps therefore optionally may includesparing the facet joints, which are directly over the nerve roots of thespine, and removing soft tissue from those joints. These steps mayfurther optionally include accessing a disc that is to be removed orotherwise treated on its symptomatic side (in the case of scoliosis, forexample, this would be the concave side) and removing all or a portionof that disc. Other steps performed at or near this time optionally mayinclude inserting one or more pedicle screws at one or more desiredlocations (e.g., in the L4 and L5 pedicles), inserting a disc spacedistractor and distracting the disc space by any one or more techniquesfor doing so that are known to the skilled artisan. Still further, othersteps at this time optionally may include carrying out a radicaldiscectomy, which may include preparing end plates for fusion, removingsoft tissue along the anterior and lateral rims of the disc space, andpacking graft material anteriorally, and/or contralaterally, in thatspace.

In a specific embodiment, which is outlined in the flow diagram of FIG.11 and depicted in FIGS. 12-14, a method 300 includes a step 310 ofpassing spacer 100 through a patient's back 5 and contacting bottomsurface 140 of spacer 100 to inferior vertebra 30 at top surface 31.FIG. 12 shows spacer 100 positioned on top surface 31 of inferiorvertebra 30 after spacer 100 has been passed through patient's back 5.Step 310 is preferably carried out by using positioning tool 200. Forexample, tip 232 of positioning tool 200 may be securably and removablyinserted into port 170 a of first spacer contact surface 150 of spacer100, while spacer 100 is outside the patient, or at least outside thepatient's spine, and then moved onto top surface 31. Alternatively,positioning tool 200 could be engaged with spacer 100 subsequent to apartial insertion of spacer 100 in the patient's spine. In this regard,a separate tool could be utilized to partially insert spacer 100.

After spacer 100 is contacted to top surface 31, a step 320 is carriedout wherein spacer 100 is oriented such that it is positioned at a sideregion 37 of top surface 31 at a substantially right angle with respectto anterior region 35 of top surface 31 by placing tip 232 ofretractable member 230 into port 170 a of first contact surface 150,and/or contacting contact surface 224 to first contact surface 150, andmoving spacer 100 substantially in a direction 38 along top surface 31by moving positioning tool 200 substantially in direction 38. FIG. 12shows spacer 100 at side region 37 and substantially at a right anglewith respect to anterior region 35 of inferior vertebra 30 after spacer100 has been moved into that position by using positioning tool 200.

Next, a step 330 is carried out wherein spacer 100 is oriented such thatspacer 100 is positioned substantially at end plate portion 34 ofinferior vertebra 30 at an angle that is not substantially a right anglewith respect to anterior region 35 of inferior vertebra 30, by insertingtip 232 into port 170 b of second contact surface 160, and/or contactingcontact surface 224 to second contact surface 160, and then movingspacer 100 substantially in direction 38, for example, along top surface31 by moving positioning tool 200 substantially in direction 38. FIG. 13shows spacer 100 in position at the cancellous bone portion, or endplate portion 34, at an angle that is not substantially a right anglewith respect to anterior region 35 after spacer 100 has been moved intothat position by using the positioning tool 200. Specifically, duringstep 330, due to the increased frictional characteristics of spacer 100at front end 106, rear end 103 of spacer 100 moves more freely indirection on top surface 31 of inferior vertebra 30 compared to themovement of front end 106. Thus, spacer 100 tends to turn according toits curved profile. This turning tends to reorient spacer 100 such thatits longitudinal axis moves toward a parallel orientation with respectto anterior region 35, i.e. a medial-lateral axis of the adjacentvertebra. In addition, at this stage of method 300, front end 106reaches the stiffer cortical rim 33 where it can move or slide moreeasily than it can on the softer cancellous bone, or end plate portion34.

Next, a step 340 is carried out wherein spacer 100 is moved into aposition that is near and substantially parallel to anterior region 35,approximating desirable location 36 upon cortical rim 33 of inferiorvertebra 30. This is achieved by inserting tip 232 into port 170 c ofsecond side surface 120, and/or contacting contact surface 224 to secondside surface 120, and then moving spacer 100 along top surface 31 bymoving positioning tool 200 in direction 38. FIG. 14 shows spacer 100substantially at desirable location 36.

It is important to note that the curved nature of spacer 100 along withits differently angled ports 170 allow for posterior insertion of spacer100 to desirable location 36. That is, a linear tool such as positioningtool 200 is all that is necessary to rotate spacer 90° with respect totop surface 31. This is made possible through the configuration ofspacer 100 itself. More specifically, as the configuration of front end106 curves spacer 100 during insertion, different ports 170 are exposedto the posterior insertion site, and thus are exposed for manipulationby positioning tool 200. Tip 232 may therefore be inserted into a port170, and as spacer 100 tends to curve during insertion, tip 232 may beremoved from port 170 and contact surface 224 may be utilized to furtherpush, and therefore rotate, spacer 100. This will, in turn, exposeanother port 170, which may be utilized by positioning tool 200 asinsertion continues. This cooperation between the curving nature ofspacer 100 and the re-positioning of positioning tool 200 with respectto rear end 103 of spacer and ports 170 makes it possible to posteriorlyinsert a longitudinal spacer, such as spacer 100, into a position suchas desirable location 36, which is along a medial-lateral axis of theintervertebral disc space. Moreover, all of this is accomplished whileonly moving tool 200 in direction 38.

FIG. 15 shows spacer 100 at desirable location 36 after positioning tool200 has been removed from the patient. It is a goal of method 300 forspacer 100 to remain at desirable location 36 after method 300 has beencarried out. The skilled artisan will recognize that there are a numberof options for securing spacer 100 at its ultimate location, i.e.desirable location 36. For example, one or more expandable set screwsmay be used to secure spacer 100. When one or more set screws are usedin this fashion, it is expected that spacer 100 will expand by a smallamount, such as several millimeters, for example. When spacer 100 soexpands, it is expected that lordosis will be effected or will befurther effected, anterior distraction will be enhanced, and openings112 within spacer 100 will expand to allow for addition of graftmaterial into openings 112.

Further, it is to be understood that although method 300 has beendescribed herein with respect to steps 310-340, one or more variationsmay be made to method 300. For example, a surgeon carrying out method300 may elect to use two positioning tools 200 concomitantly whilecarrying out one or more of positioning steps 310-340 of method 300. Thesurgeon therefore may, for example, insert tip 232 of one positioningtool 200 into port 170 a and tip 232 of a second positioning tool 200into port 170 b, and then position spacer 100 essentially according tostep 320 of method 300 before then positioning spacer 100 essentiallyaccording to step 330 of method 300, while throughout this procedure,tips 232 remain within ports 170 a, 170 b, respectively. Alternatively,a single positioning tool may be arranged to enable complete steerage ofspacer 100 to desirable location 36 without disconnecting thepositioning tool from spacer 100.

Further embodiments of a spacer according to the present invention willnow be described, each spacer having one or more off-axis positioninginterface sites. There are a plurality of embodiments of the spacer,wherein each includes one or more positioning interface sites at alocation or locations on the body of the spacer that are not alignedwith or parallel to the primary longitudinal axis of the spacer. Inaddition to being beneficial for the precise positioning of the spacer,the at least one off-axis interface may be utilized as the onlyinterface for modification of the spacer, or as an interface for furthermodification of the spacer after the use of one or more otherinterfaces. The modification can be for expansion or size alteration,which will be further discussed below. Such further modification maytake place after the spacer is finally positioned or at any stage duringthe insertion process. In general, as shown in FIGS. 16-17, a spacerused in an IF procedure may be characterized as having a primarylongitudinal length axis L, a width axis W, and a height axis H, eachbeing an orthogonal axis of the spacer. The terms “on-axis” and“off-axis” will be herein referred to as describing their relation tolongitudinal length axis L of a spacer. An “on-axis” port, for example,is one that is aligned with or parallel to length axis L, whereas an“off-axis” port, for example, is one that is not aligned with orparallel to length axis L. A spacer according to the present inventionpreferably includes at least one on-axis positioning interface site andat least one off-axis positioning interface site. An off-axispositioning interface site may include, but is not limited to,non-orthogonal locations and at, along, or parallel to either or both ofwidth axis W and height axis H.

The existence of at least one off-axis positioning interface site of thebody of the spacer of the present invention provides the surgeon withthe opportunity to direct the placement of the spacer at something otherthan straight ahead longitudinal movement, i.e. along aposterior-anterior axis. A positioning tool may be removably joined tothe spacer at an interface site and manipulated to cause movement of thespacer. Further, the tool may remain attached to the spacer and berealigned in an off-axis manner. When the positioning tool is joined to,or realigned with respect to, the spacer at an off-axis interface andthe tool is moved, the spacer moves at an angle with respect to thealignment of the positioning tool, which angle may be orthogonal ornon-orthogonal. That is to say that the spacer tends to move along anaxis of the positioning tool, regardless of the location at which thepositioning tool is connected to the spacer. Thus, the length axis L ofthe spacer may be angled with respect to the axis of the positioningtool during such insertion. The result is that a surgeon mayadvantageously manipulate the spacer with finer control than has beenavailable with the existing spacers.

FIGS. 16-18 illustrate another embodiment of an off-axis spacer 400 ofthe present invention. Spacer 400 includes a top surface 430, a bottomsurface 440 that is preferably a mirror image of top surface 430, firstand second sides 415 and 425, respectively, that are mirror images ofone another, a front end 485, and a rear end 495 that is preferably amirror image of front end 485. First side 415 includes a first sidesurface 410, and second side 425 includes a second side surface 420.Similarly, front end 485 includes a front surface 480, and rear end 495includes a rear surface 490. Top surface 430 includes an optional topinterface port 431 configured and arranged for releasably connecting toa positioning tool, such as aforementioned positioning tool 200. Topinterface port 431 may be a smooth bore hole, a threaded hole, or aslotted hole. Top interface port 431 may or may not extend completelythrough from top surface 430 to bottom surface 440. Alternatively,spacer 400 may be constructed such that it includes one or moreconnecting elements in addition to or instead of top interface port 431that may be a rod, a hook, or any other means rather than a port forreleasably joining to a positioning tool. It is to be noted that bottomsurface 440 may also include such an interface, there may be fewer thanor more than one interface at either or both of top surface 430 andbottom surface 440, and there may be different numbers of connectingmeans at top surface 430 and bottom surface 440. Spacer 400 may befabricated as a unitary structure or it may be fabricated of a pluralityof sections. It may be of fixed dimensions or expandable. It may befabricated of one or more materials of interest, provided such materialis selected to enable spacer 400 to perform for its intended purposeunder the expected conditions.

It is to be noted that top interface port 431 is an off-axis axialinterface. That is, it is not aligned or in parallel with length axis L.Rather, in this instance, top interface port 431 is parallel tonon-primary height axis H. Top surface 430 and bottom surface 440 ofspacer 400 are those surfaces that contact the adjacent vertebrae andestablish the spacing surfaces of spacer 400 and their separation fromone another establishes the height of spacer 400. Placement of aninterface on either top surface 430 or bottom surface 440 is optional,but does provide the surgeon with flexibility in at least the initialstages of spacer placement. Of course, it is to be understood that theremay be through holes (not shown) extending from top surface 430 tobottom surface 440 to allow for bone graft packing and growththerethrough to secure spacer 400 in position as part of the IFprocedure.

Spacer 400 further includes a plurality of chamfered sections. Firstchamfered section 402 and second chamfered section 404 are located atrear end 495 of spacer 400, while third chamfered section 406 and fourthchamfered section 408 are located at front end 485 of spacer 400.Further, first chamfered section 402 and third chamfered section 406 arelocated at first side 415 of spacer 400, while second chamfered section404 and fourth chamfered section 408 are located at second side 425 ofspacer 400. First chamfered section 402 is spaced from and connected tosecond chamfered section 404 by rear surface 490 of spacer 400, andthird chamfered section 406 is spaced from and connected to fourthchamfered section 408 by front surface 480 of spacer 400. In addition,first chamfered section 402 is spaced from and connected to thirdchamfered section 406 by first side surface 410 of spacer 400, andsecond chamfered section 404 is spaced from and connected to fourthchamfered section 408 by second side surface 420 of spacer 400.

One or more of chamfered sections 402, 404, 406, and 408 may include oneor more chamfered interface ports 409 configured and arranged forreleasably connecting to a positioning tool. Preferably, either or bothof chamfered sections 402 and 404 associated with rear end 495 include achamfered interface port 409, because spacer 400 is intended to be movedto the location of interest by directing the front of spacer 400 towardthe end plate, such as end plate portion 34 shown in FIG. 2, by pushingon an area at or adjacent to rear end 495 of spacer 400, which mayoptionally include first side 415 and/or second side 425. The angles ofeach of chamfered sections 402, 404, 406, and 408 with respect to lengthaxis L may all be the same. Alternatively, only certain of such anglesmay be the same, or they may each be different. Of course, any ofchamfered sections 402, 404, 406, and 408 may also be angled withrespect to width axis W and/or height axis H. Chamfered interface ports409 establish non-axial, or off-axis, interfaces of spacer 400 in thatthey are not aligned or parallel with any major axis of the body ofspacer 400. Chamfered interface ports 409 may be smooth bore holes,threaded holes, or slotted holes. Alternatively, spacer 400 may beconstructed such that it includes one or more connecting elements inaddition to or instead of chamfered interface ports 409 that may be arod, a hook, or any other means rather than a port for releasablyjoining to a positioning tool.

Rear surface 490 preferably, but not necessarily, includes a rearinterface port 491 configured and arranged for releasably connecting toa positioning tool. Rear interface port 491 may be a smooth bore hole, athreaded hole, or a slotted hole. Rear interface port 491 may or may notextend completely through spacer 400 from rear surface 490 to frontsurface 480. Alternatively, spacer 400 may be constructed such that itincludes one or more connecting elements in addition to or instead ofrear interface port 491 that may be a rod, a hook, or any other meansrather than a port for releasably joining to a positioning tool. It isto be noted that front surface 480 may also optionally include such aninterface (when rear interface port 491 does not extend all the waythrough), there may be fewer than or more than one interface at eitheror both of rear surface 490 and front surface 480, and there may bedifferent numbers of connecting means at rear surface 490 and frontsurface 480.

It is to be noted that rear interface port 491 is an on-axis axialinterface. That is, it is aligned or in parallel with primarylongitudinal length axis L. In this instance, rear interface port 491 isan on-axis contact location. The distance from rear surface 490 to frontsurface 480 establishes the length of spacer 400. Placement of aninterface on either rear surface 490 or front surface 480 is optional,but doing so provides the surgeon with flexibility in the course ofspacer placement.

First side 415, and specifically first side surface 410, of spacer 400optionally includes one or more first side interface ports 411configured and arranged for releasably connecting to a positioning tool.Of course, the same could be true for second side 425 and second sidesurface 420. First side interface port 411 may be a smooth bore hole, athreaded hole, or a slotted hole. First side interface port 411 may ormay not extend completely through from first side surface 410 to secondside surface 420. Alternatively, spacer 400 may be constructed such thatit includes one or more connecting elements in addition to or instead offirst side interface port 411 that may be a rod, a hook, or any othermeans rather than a port for releasably joining to a positioning tool.It is to be noted that there may be fewer than or more than oneinterface at either or both of first side surface 410 and second sidesurface 420, and there may be different numbers of connecting means atfirst side surface 410 and second side surface 420.

First side interface port 411 is an off-axis axial interface. That is,it is not aligned or in parallel with length axis L. Rather, in thisinstance first side interface port 411 is parallel to non-primary widthaxis W. The distance from first side surface 410 to second side surface420 establishes the width of spacer 400. Placement of an interface oneither or both of first side surface 410 and second side surface 420 isoptional, but doing so provides the surgeon with flexibility in thecourse of spacer placement.

An illustrative manner of using a spacer according to the presentinvention is now described, with particular reference to spacer 400.Initially, the surgeon preferably performs preliminary steps ordinarilycarried out in the course of an IF procedure. When it is time to insertspacer 400 in the intervertebral disc space, a positioning tool, such asabove-described positioning tool 200, is connected to spacer 400 at oneof the interface ports described above. If the surgeon wishes to advancespacer 400 along its longitudinal axis, i.e., along an axis parallel tolength L, the positioning tool is joined to spacer 400 at one of theon-axis positioning interfaces, such as rear interface port 491, forexample. During insertion when the surgeon wishes to cause spacer 400 toturn at an angle or in a curving manner, the positioning tool may bereleased from its connection to the axial, or on-axis, port andre-connected to spacer 400 at an off-axis port. Of course, thepositioning tool need not immediately be repositioned into a port; itmay be used to manipulate spacer 400 from any of its exterior surfaces.Alternatively, the positioning tool may remain connected to spacer 400and realigned in an off-axis manner at one of the off-axis positioninginterfaces, such as chamfered interface port 409 of first chamferedsection 402, for example. The surgeon may continue to advance spacer 400by pushing on the positioning tool when it is connected to spacer 400until it reaches a final selected location. Throughout such advancement,the orientation of the positioning tool may be changed with respect tospacer 400, wherein the surgeon disconnects the positioning tool fromthe off-axis interface and re-connects it to a different (preferablyoff-axis) interface, such as first side interface port 411 of first sidesurface 410, for example. The surgeon may use spacer 400 and thepositioning tool to fine tune the placement of spacer 400 at a desiredlocation through the use of one or more of the off-axis interfaces and,optionally, the on-axis interface. The surgeon may also wish to expandspacer 400 using any of the off-axis and on-axis interfaces.

The positioning tool 200 is preferably used to position the spacersubstantially between the outer, dense portions of vertebrae, betweenwhich an intervertebral disc has been surgically removed, but is notlimited thereto. Tip 232 is inserted into a selected interface port andreleasably secured thereto. Retractable member 230 is then extended toforce the spacer forward, either directly or at an angle or in a curvedmanner, dependent upon the interface port selected and the spacerdesign. Upon reaching a position of interest, tip 232 is released fromits connection to the interface port, retractable member 230 iswithdrawn, and tip 232 is moved to connect with another off-axisinterface port. The process is repeated until the surgeon is satisfiedthat the spacer has been positioned substantially in the location ofinterest.

Therefore, spacer 400 may be positioned at desirable location 36 throughthe use of an axial or linear positioning tool, such as positioning tool200. The positioning tool is preferably first aligned with an on-axisport of spacer 400 during initial insertion. After spacer 400 ismaneuvered into the disc space, the positioning tool may be disconnectedfrom the on-axis port and reconnected with one or more off-axis ports asnecessary to further maneuver spacer 400 into desirable location 36. Aspacer according to this embodiment of the present invention may alsoinclude a self-steering aspect which will allow spacer 400 to orientitself in the disc space while being aided in such orientation by thepositioning tool. An advantageous aspect of this method is that thepositioning tool may be utilized in a substantially posterior-anteriordirection, which is due to its repeated disconnection and reconnectionto the posterior-most facing port of spacer 400 as spacer 400 rotatesinto its final position. The results is a procedure that utilizes astandard or existing positioning tool in order to insert and rotatespacer 400.

FIGS. 19-22 illustrate another embodiment of an off-axis spacer 500 ofthe present invention. Spacer 500 is similar to spacer 400 of FIGS.16-18, except that it is not symmetrical with respect to its forwarddesign. That is, a top surface 530 of spacer 500 is not symmetrical withrespect to any axis parallel to width axis W. Spacer 500 may be used inthe same manner as that described with respect spacer 400. Spacer 500includes top surface 530, a bottom surface 540 that is preferably amirror image of top surface 530, first and second sides 515 and 525,respectively, which are mirror images of one another, a front end 585and a rear end 595. First side 515 includes a first side surface 510,and second side 525 includes a second side surface 520. Similarly, frontend 585 includes a front surface 580, and rear end 595 includes a rearsurface 590. Top surface 530 includes an optional top interface port 531configured and arranged for releasably connecting to a positioning tool,such as aforementioned positioning tool 200. Top interface port 531 maybe a smooth bore hole, a threaded hole, or a slotted hole. Top interfaceport 531 may or may not extend completely through from top surface 530to bottom surface 540. Alternatively, spacer 500 may be constructed suchthat it includes one or more connecting elements in addition to orinstead of top interface port 531 that may be a rod, a hook, or anyother means rather than a port for releasably joining to a positioningtool. It is to be noted that bottom surface 540 may also include such aninterface, there may be fewer than or more than one interface at eitheror both of top surface 530 and bottom surface 540, and there may bedifferent numbers of connecting means at top surface 530 and bottomsurface 540. Spacer 500 may be fabricated as a unitary structure or itmay be fabricated of a plurality of sections. It may be of fixeddimensions or expandable. It may be fabricated of one or more materialsof interest, provided such material is selected to enable spacer 500 toperform for its intended purpose under the expected conditions.

It is to be noted that top interface port 531 is an off-axis axialinterface aligned with non-primary height axis H of spacer 500. Topsurface 530 and bottom surface 540 of spacer 500 are those surfaces thatcontact the adjacent vertebrae and establish the spacing surfaces ofspacer 500 and their separation from one another establishes the heightof spacer 500. Placement of an interface on either top surface 530 orbottom surface 540 is optional, but does provide the surgeon withflexibility in at least the initial stages of spacer placement. Ofcourse, it is to be understood that there may be through holes (notshown) extending from top surface 530 to bottom surface 540 to allow forbone graft packing and growth therethrough to secure spacer 500 inposition as part of the IF procedure.

Spacer 500 further includes a plurality of chamfered sections. Firstchamfered section 502 and second chamfered section 504 are located atrear end 595 of spacer 500. First chamfered section 502 is spaced fromand connected to second chamfered section 504 by rear surface 590 ofspacer 500. Front surface 580 is substantially parallel to rear surface590, and front surface 580 is connected directly to first side surface510 and second side surface 520, not by way of any chamfered sections.

One or both of first and second chamfered sections 502 and 504,respectively, may include one or more chamfered interface ports 509configured and arranged for releasably connecting to a positioning tool.The angles of each of chamfered sections 502 and 504 with respect tolength axis L may be the same or they may be different. Of course, anyof chamfered sections 502 and 504 may also be angled with respect towidth axis W and/or height axis H. Chamfered interface ports 509establish non-axial interfaces of spacer 500 in that they are notaligned or parallel with any major axis of the body of spacer 500.Chamfered interface ports 509 may be smooth bore holes, threaded holes,or slotted holes. Alternatively, spacer 500 may be constructed such thatit includes one or more connecting elements in addition to or instead ofchamfered interface ports 509 that may be a rod, a hook, or any othermeans rather than a port for releasably joining to a positioning tool.

Rear surface 590 preferably, but not necessarily, includes a rearinterface port 591 configured and arranged for releasably connecting toa positioning tool. Rear interface port 591 may be a smooth bore hole, athreaded hole, or a slotted hole. Rear interface port 591 may or may notextend completely through spacer 500 from rear surface 590 to frontsurface 580. Alternatively, spacer 500 may be constructed such that itincludes one or more connecting elements in addition to or instead ofrear interface port 591 that may be a rod, a hook, or any other meansrather than a port for releasably joining to a positioning tool. It isto be noted that front surface 580 may also optionally include a frontinterface port 581 (when rear interface port 591 does not extend all theway through), there may be fewer than or more than one interface ateither or both of rear surface 590 and front surface 580, and there maybe different numbers of connecting means at rear surface 590 and frontsurface 580.

It is to be noted that rear interface port 591 and front interface port581 are on-axis axial interfaces aligned or in parallel with primarylongitudinal length axis L of spacer 500. The distance from rear surface590 to front surface 580 establishes the length of spacer 500. Placementof an interface on either rear surface 590 or front surface 580 isoptional, but doing so provides the surgeon with flexibility in thecourse of spacer placement.

First side 515, and specifically first side surface 510, of spacer 500optionally includes one or more first side interface ports 511configured and arranged for releasably connecting to a positioning tool.Of course, the same could be true for second side 525 and second sidesurface 520. First side interface port 511 may be a smooth bore hole, athreaded hole, or a slotted hole. First side interface port 511 may ormay not extend completely through from first side surface 510 to secondside surface 520. Alternatively, spacer 500 may be constructed such thatit includes one or more connecting elements in addition to or instead offirst side interface port 511 that may be a rod, a hook, or any othermeans rather than a port for releasably joining to a positioning tool.It is to be noted that there may be fewer than or more than oneinterface at either or both of first side surface 510 and second sidesurface 520, and there may be different numbers of connecting means atfirst side surface 510 and second side surface 520.

First side interface port 511 is an off-axis axial interface aligned orin parallel with non-primary width axis W of spacer 500. The distancefrom first side surface 510 to second side surface 520 establishes thewidth of spacer 500. Placement of one or more interfaces on either orboth of first side surface 510 and second side surface 520 is optional,but doing so provides the surgeon with flexibility in the course ofspacer placement.

FIGS. 23-26 illustrate another embodiment of an off-axis spacer 600 ofthe present invention. Spacer 600 is similar to spacer 500 of FIGS.19-22, except that it is not symmetrical with respect to its reardesign. That is, a top surface 630 of spacer 600 is not symmetrical withrespect to any axis parallel to width axis W or length axis L. Spacer600 may be used in the same manner as that described with respect tospacer 400. Spacer 600 includes a top surface 630, a bottom surface 640that is preferably a mirror image of top surface 630, first and secondsides 615 and 625, respectively, that are mirror images of one another,a front end 685 and a rear end 695. First side 615 includes a first sidesurface 610, and second side 625 includes a second side surface 620.Similarly, front end 685 includes a front surface 680, and rear end 695includes a rear surface 690. Top surface 630 includes an optional topinterface port 631 configured and arranged for releasably connecting toa positioning tool, such as aforementioned positioning tool 200. Topinterface port 631 may be a smooth bore hole, a threaded hole, or aslotted hole. Top interface port 631 may or may not extend completelythrough from top surface 630 to bottom surface 640. Alternatively,spacer 600 may be constructed such that it includes one or moreconnecting elements in addition to or instead of top interface port 631that may be a rod, a hook, or any other means rather than a port forreleasably joining to a positioning tool. It is to be noted that bottomsurface 640 may also include such an interface, there may be fewer thanor more than one interface at either or both of top surface 630 andbottom surface 640, and there may be different numbers of connectingmeans at top surface 630 and bottom surface 640. Spacer 600 may befabricated as a unitary structure or it may be fabricated of a pluralityof sections. It may be of fixed dimensions or expandable. It may befabricated of one or more materials of interest, provided such materialis selected to enable spacer 600 to perform for its intended purposeunder the expected conditions.

It is to be noted that top interface port 631 is an off-axis axialinterface aligned with non-primary height axis H of spacer 600. Topsurface 630 and bottom surface 640 of spacer 600 are those surfaces thatcontact the adjacent vertebrae and establish the spacing surfaces ofspacer 600 and their separation from one another establishes the heightof spacer 600. Placement of an interface on either top surface 630 orbottom surface 640 is optional, but does provide the surgeon withflexibility in at least the initial stages of spacer placement. Ofcourse, it is to be understood that there may be through holes (notshown) extending from top surface 630 to bottom surface 640 to allow forbone graft packing and growth therethrough to secure spacer 600 inposition as part of the IF procedure.

Spacer 600 further includes chamfered section 602 located at rear end695 of spacer 600. Chamfered section 602 extends from rear surface 690to first side surface 610. Front surface 680 is substantially parallelto rear surface 690, and front surface 680 is connected directly tofirst side surface 610 and second side surface 620, not by way of anychamfered sections.

Chamfered section 602 includes a chamfered interface port 609 configuredand arranged for releasably connecting to a positioning tool. The angleof the chamfered section 602 with respect to length axis L isselectable. Of course, chamfered sections 602 may also be angled withrespect to width axis W and/or height axis H. Chamfered interface port609 establishes a non-axial interface of spacer 600 in that it is notaligned or parallel with any major axis of the body of spacer 600.Chamfered interface port 609 may be a smooth bore hole, a threaded hole,or a slotted hole. Alternatively, spacer 600 may be constructed suchthat it includes one or more connecting elements in addition to orinstead of chamfered interface port 609 that may be a rod, a hook, orany other means rather than a port for releasably joining to apositioning tool.

Rear surface 690 preferably, but not necessarily, includes a rearinterface port 691 configured and arranged for releasably connecting toa positioning tool. Rear interface port 691 may be a smooth bore hole, athreaded hole, or a slotted hole. Rear interface port 691 may or may notextend completely through spacer 600 from rear surface 690 to frontsurface 680. Alternatively, spacer 600 may be constructed such that itincludes one or more connecting elements in addition to or instead ofrear interface port 691 that may be a rod, a hook, or any other meansrather than a port for releasably joining to a positioning tool. It isto be noted that front surface 680 may also optionally include a frontinterface port 681 (when rear interface port 691 does not extend all theway through), there may be fewer than or more than one interface port ateither or both of rear surface 690 and front surface 680, and there maybe different numbers of connecting means at rear surface 690 and frontsurface 680.

It is to be noted that rear interface port 691 and front interface port681 are on-axis axial interfaces aligned or in parallel with primarylongitudinal length axis L of spacer 600. The distance from rear surface690 to front surface 680 establishes the length of spacer 600. Placementof an interface on either rear surface 690 or front surface 680 isoptional, but doing so provides the surgeon with flexibility in thecourse of spacer placement.

First side 615, and specifically first side surface 610, of spacer 600optionally includes one or more first side interface ports 611configured and arranged for releasably connecting to a positioning tool.Of course, the same could be true for second side 625 and second sidesurface 620. First side interface port 611 may be a smooth bore hole, athreaded hole, or a slotted hole. First side interface port 611 may ormay not extend completely through from first side surface 610 to secondside surface 620. Alternatively, spacer 600 may be constructed such thatit includes one or more connecting elements in addition to or instead offirst side interface port 611 that may be a rod, a hook, or any othermeans rather than a port for releasably joining to a positioning tool.It is to be noted that there may be fewer than or more than oneinterface at either or both of first side surface 610 and second sidesurface 620, and there may be different numbers of connecting means atfirst side surface 610 and second side surface 620.

First side interface port 611 is an off-axis axial interface aligned orin parallel with the non-primary width axis W of spacer 600. Thedistance from first side surface 610 to second side surface 620establishes the width of spacer 600. Placement of one or more interfaceports on either or both of the first side surface 610 and second sidesurface 620 is optional, but doing so provides the surgeon withflexibility in the course of spacer placement.

FIGS. 27-29 illustrate another embodiment of an off-axis spacer 700 ofthe present invention. Spacer 700 is similar to spacer 500 of FIGS.19-22, except that it has a curved forward design 701. Spacer 700 may beused in the same manner as that described with respect to spacer 400,although curved forward design 701 enables curving movement of spacer700 more readily than may be achieved with any other spacer embodimentsherein described. Spacer 700 includes a top surface 730, a bottomsurface 740 that is preferably a mirror image of top surface 730, firstand second sides 715 and 725, respectively, a front end 785 and a rearend 795. First side 715 includes a first side surface 710, and secondside 725 includes a second side surface 720. Similarly, front end 785includes a front surface 780, and rear end 795 includes a rear surface790. Top surface 730 includes an optional top interface port 731configured and arranged for releasably connecting to a positioning tool,such as aforementioned positioning tool 200. Top interface port 731 maybe a smooth bore hole, a threaded hole, or a slotted hole. Top interfaceport 731 may or may not extend completely through from top surface 730to bottom surface 740. Alternatively, spacer 700 may be constructed suchthat it includes one or more connecting elements in addition to orinstead of top interface port 731 that may be a rod, a hook, or anyother means rather than a port for releasably joining to a positioningtool. It is to be noted that bottom surface 740 may also include such aninterface, there may be fewer than or more than one interface at eitheror both of top surface 730 and bottom surface 740, and there may bedifferent numbers of connecting means at top surface 730 and bottomsurface 740. Spacer 700 may be fabricated as a unitary structure or itmay be fabricated of a plurality of sections. It may be of fixeddimensions or expandable. It may be fabricated of one or more materialsof interest, provided such material is selected to enable spacer 700 toperform for its intended purpose under the expected conditions.

It is to be noted that top interface port 731 is an off-axis axialinterface aligned with non-primary height axis H of spacer 700. Topsurface 730 and bottom surface 740 of spacer 700 are those surfaces thatcontact the adjacent vertebrae and establish the spacing surfaces ofspacer 700 and their separation from one another establishes the heightof spacer 700. Placement of an interface on either top surface 730 orbottom surface 740 is optional, but does provide the surgeon withflexibility in at least the initial stages of spacer placement. Ofcourse, it is to be understood that there may be through holes (notshown) extending from top surface 730 to bottom surface 740 to allow forbone graft packing and growth therethrough to secure spacer 700 inposition as part of the IF procedure.

Spacer 700 further includes a plurality of chamfered sections. Firstchamfered section 702 and second chamfered section 704 are located atrear end 795 of spacer 700. First chamfered section 702 is spaced fromand connected to second chamfered section 704 by rear surface 790 ofspacer 700. Front end 780 is arranged to enable steerable movement ofspacer 700 to a location of interest, such as desirable location 36. Inthe embodiment shown in FIGS. 27-29, front end 780 includes curvedforward design 701, which may be of different configuration provided itundertakes curving movement when spacer 700 is pushed with a positioningtool. Curved forward design 701 may also be beveled or otherwise shapedto increase its friction with respect to the surface of end plate onwhich it rides so that it is inclined to dig into the end plate and beforced to turn in a direction associated with the direction of itscurved form. That is, the curved form of front end 780 is preferablyconfigured to produce greater friction between the end plate and theremaining portions of the body of spacer 700, including rear end 795.

One or both of first and second chamfered sections 702 and 704,respectively, may include one or more chamfered interface ports 709configured and arranged for releasably connecting to a positioning tool.The angles of each of chamfered sections 702 and 704 with respect tolength axis L may be the same or they may be different. Of course, anyof chamfered sections 702 and 704 may also be angled with respect towidth axis W and/or height axis H. Chamfered interface ports 709establish non-axial, or off-axis, interfaces of spacer 700 in that theyare not aligned or parallel with any major axis of the body of spacer700. Chamfered interface ports 709 may be smooth bore holes, threadedholes, or slotted holes. Alternatively, spacer 700 may be constructedsuch that it includes one or more connecting elements in addition to orinstead of chamfered interface ports 709 that may be a rod, a hook, orany other means rather than a port for releasably joining to apositioning tool.

Rear surface 790 preferably, but not necessarily, includes a rearinterface port 791 configured and arranged for releasably connecting toa positioning tool. Rear interface port 791 may be a smooth bore hole, athreaded hole, or a slotted hole. Rear interface port 791 may or may notextend completely through spacer 700 from rear surface 790 to frontsurface 780 of spacer 700. Alternatively, spacer 700 may be constructedsuch that it includes one or more connecting elements in addition to orinstead of rear interface port 791 that may be a rod, a hook, or anyother means rather than a port for releasably joining to a positioningtool. There may be fewer than or more than one interface at rear surface790.

It is to be noted that rear interface port 791 is an on-axis interfaceand is aligned or in parallel with primary longitudinal length axis L ofspacer 700. The distance from rear surface 790 to an end 782 of frontend 780 establishes the length of spacer 700. Placement of an interfaceon rear surface 790 is optional, but doing so provides the surgeon withflexibility in the course of spacer placement.

First side 715 and specifically first side surface 710, of spacer 700optionally includes one or more first side interface ports 711configured and arranged for releasably connecting to a positioning tool.Of course, the same could be true for second side 725 and second sidesurface 720. First side interface port 711 may be a smooth bore hole, athreaded hole, or a slotted hole. First side interface port 711 may ormay not extend completely through from first side surface 710 to secondside surface 720. Alternatively, spacer 700 may be constructed such thatit includes one or more connecting elements in addition to or instead offirst side interface port 711 that may be a rod, a hook, or any othermeans rather than a port for releasably joining to a positioning tool.It is to be noted that there may be fewer than or more than oneinterface at either or both of first side surface 710 and second sidesurface 720, and there may be different numbers of connecting means atfirst side surface 710 and second side surface 720.

First side interface port 711 is an off-axis axial interface aligned orin parallel with non-primary width axis W of spacer 700. The distancefrom first side surface 710 to second side surface 720 establishes thewidth of spacer 700. Placement of one or more interfaces on either orboth of first side surface 710 and second side surface 720 is optional,but doing so provides the surgeon with flexibility in the course ofspacer placement.

An embodiment of an off-axis expandable spacer 800 of the presentinvention is shown in FIGS. 30-33. Spacer 800 is similar to spacer 500of FIGS. 19-22, except that it is expandable rather than of staticdimensions. That is, the size and shape of spacer 800 may be modified bythe surgeon, preferably during a surgical procedure. Spacer 800 may beused in the same manner as that described with respect to any of theabove-described spacers. In addition to the ability to adjust thepositioning of spacer 800 in an on-axis manner, the size and shape ofspacer 800 may also be modified through off-axis manipulation. Spacer800 includes a top surface 830, a bottom surface 840 that is preferablya mirror image of top surface 830, first and second sides 815 and 825,respectively, that are mirror images of one another, a front end 885 anda rear end 895. First side 815 includes a first side surface 810, andsecond side 825 includes a second side surface 820. Similarly, front end885 includes a front surface 880, and rear end 895 includes a rearsurface 890. Top surface 830 includes an optional top interface port 831configured and arranged for releasably connecting to a positioning tool,such as aforementioned positioning tool 200. Top interface port 831 maybe a smooth bore hole, a threaded hole, or a slotted hole. Top interfaceport 831 may or may not extend completely through from top surface 830to bottom surface 840. Alternatively, spacer 800 may be constructed suchthat it includes one or more connecting elements in addition to orinstead of top interface port 831 that may be a rod, a hook, or anyother means rather than a port for releasably joining to the positioningtool. It is to be noted that bottom surface 840 may also include such aninterface, there may be fewer than or more than one interface at eitheror both of top surface 830 and bottom surface 840, and there may bedifferent numbers of connecting means at top surface 830 and bottomsurface 840. Spacer 800 may be fabricated as a unitary structure or itmay be fabricated of a plurality of sections. It may be fabricated ofone or more materials of interest, provided such material is selected toenable spacer 800 to perform for its intended purpose under the expectedconditions.

It is to be noted that top interface port 831 is an off-axis axialinterface aligned with non-primary height axis H of spacer 800. Topsurface 830 and bottom surface 840 of spacer 800 are those faces thatcontact the adjacent vertebrae and establish the spacing surfaces ofspacer 800 and their separation from one another establishes the heightof spacer 800. Placement of an interface on either top surface 830 orbottom surface 840 is optional, but does provide the surgeon withflexibility in at least the initial stages of spacer placement. Ofcourse, it is to be understood that there may be through holes (notshown) extending from top surface 830 to bottom surface 840 to allow forbone graft packing and growth therethrough to secure spacer 800 inposition as part of the IF procedure.

Spacer 800 further includes a plurality of chamfered sections. Firstchamfered section 802 and second chamfered section 804 are located atrear end 895 of spacer 800. First chamfered section 802 is spaced fromand connected to second chamfered section 804 by rear surface 890 ofspacer 800. Front surface 880 is substantially parallel to rear surface890, and front surface 880 is connected directly to first side surface810 and second side surface 820, not by way of any chamfered sections.

One or both of first and second chamfered sections 802 and 804,respectively, may include one or more chamfered interface ports 809configured and arranged for releasably connecting to a positioning tool.The angles of each of chamfered sections 802 and 804 with respect tolength axis L may be the same or they may be different. Of course, anyof chamfered sections 802 and 804 may also be angled with respect towidth axis W and/or height axis H. Chamfered interface ports 809establish non-axial or off-axis interfaces of spacer 800 in that theyare not aligned or parallel with any major axis of the body of spacer800. Chamfered interface ports 809 may be smooth bore holes, threadedholes, or slotted holes. Alternatively, spacer 800 may be constructedsuch that it includes one or more connecting elements in addition to orinstead of chamfered interface ports 809 that may be a rod, a hook, orany other means rather than a port for releasably joining to apositioning tool.

Rear surface 890 preferably, but not necessarily, includes a rearinterface port 891 configured and arranged for releasably connecting toa positioning tool, or as shown in FIGS. 31 and 33, an expander 897.Rear interface port 891 may be a smooth bore hole, a threaded hole, or aslotted hole. Rear interface port 891 may or may not extend completelythrough spacer 800 from rear surface 890 to front surface 880 of spacer800. There may be fewer than or more than one interface at rear surface890.

It is to be noted that rear interface port 891 is an on-axis interfaceand is aligned or in parallel with primary longitudinal length axis L ofspacer 800. The distance from rear surface 890 to an end 882 of frontend 880 establishes the length of spacer 800. Placement of an interfaceon rear surface 890 is optional, but doing so provides the surgeon withflexibility in the course of spacer placement and/or expansion.

First side 815 and specifically first side surface 810, of spacer 800optionally includes one or more first side interface ports 811configured and arranged for releasably connecting to a positioning tool.Of course, the same could be true for second side 825 and second sidesurface 820. First side interface port 811 may be a smooth bore hole, athreaded hole, or a slotted hole. First side interface port 811 may ormay not extend completely through from first side surface 810 to secondside surface 820. Alternatively, spacer 800 may be constructed such thatit includes one or more connecting elements in addition to or instead offirst side interface port 811 that may be a rod, a hook, or any othermeans rather than a port for releasably joining to the positioning tool.It is to be noted that there may be fewer than or more than oneinterface at either or both of first side surface 810 and second sidesurface 820, and there may be different numbers of connecting means atfirst side surface 810 and second side surface 820.

First side interface port 811 is an off-axis axial interface aligned orin parallel with non-primary width axis W of spacer 800. The distancefrom first side surface 810 to second side surface 820 establishes thewidth of spacer 800. Placement of one or more interfaces on either orboth of first side surface 810 and second side surface 820 is optional,but doing so provides the surgeon with flexibility in the course ofspacer placement.

As spacer 800 is expandable, it includes means for its expansion.Further shown in FIGS. 30-33, the spacer 800 includes an expansionchannel 896 extending partially through from rear end 895. Expansionchannel 896 may coincide with rear interface port 891 or may be separatetherefrom. It may optionally extend all the way through to front end 885of spacer 800. Although shown as an on-axis expansion channel, it is tobe understood that expansion channel 896 may be of an off-axisarrangement. That is, expansion channel 896 may be located at anoff-axis position. Moreover, it is contemplated that any of theinterfaces herein, both on-axis and off-axis, may be coincident with anexpansion channel similar to expansion channel 896. An expansion channelaccording to the present invention may thusly be of an on-axis or anoff-axis arrangement, and more than one expansion channel may beprovided in a spacer. Spacer 800 further includes expander 897 arrangedfor removable or permanent insertion into expansion channel 896.Expansion channel 896 and expander 897 are arranged such that whenexpander 897 is directed into expansion channel 896, the shape and sizeof spacer 800 may be changed. For example, as shown in FIG. 33,substantially complete insertion of expander 897 into expansion channel896 causes top surface 830 and bottom surface 840 of spacer 800 to moveapart to produce a wedge shape of spacer 800. In this example, expansionchannel 896 is threaded and expander 897 is a screw that may be threadedinto threaded expansion channel 896. However, expansion channel 896 maybe smooth and expander 897 may similarly have a smooth exterior. Inparticular, with expansion channel 896 in a wedged shape, spacer 800will become wedge-shaped. Alternatively, expansion channel 896 may be ofuniform dimensions, resulting in uniform and parallel increasedseparation of top surface 830 and bottom surface 840. Those of ordinaryskill in the art will recognize that other means of expansion may beachieved including, but not limited to, the use of wedges, cams, or thelike. It is also contemplated that a removable tool be used forexpansion in lieu of the permanently-implanted expander 897.

In use, expandable spacer 800 may be positioned at a selectable anglewith respect to the posterior-anterior axis of the disc space asdesired, based on the selection and utilization of one or more of theon-axis and/or off-axis ports described above for interfacing with thepositioning tool. The positioning tool or another tool configured withan interface releasably connectable to expander 897 may be used for anyof the above-described modification. The expansion of spacer 800 mayoccur before, during or after its positioning. The expansion may occurpartially or completely at any of those instances. As noted, expansionchannel 896 may be configured in an on-axis or an off-axis design andthe expansion tool may be adaptable for interfacing in eitherconfiguration.

Positioning spacer 800 according to the above-described method ofinsertion preferably exposes at least one off-axis interface of spacer800 generally to the posterior incision site for manipulation eitherduring implantation or after spacer 800 is finally positioned. Thus, inaddition to utilizing the at least one off-axis interface forpositioning spacer 800, the at least one off-axis interface may also beutilized for purposes of expansion, manipulation, or other types ofmodification pertaining to the size, dimension and/or shape of spacer800. This modification may occur after spacer 800 has been finallypositioned in an anterior aspect of the disc space. Such modificationmay also or alternatively occur at any point during the insertionprocess. For instance, spacer 800 may be inserted to a certain position,expanded to a determined height, and further inserted and expanded asnecessary. The ability to modify spacer 800 at an off-axis interfacegives the surgeon greater control of the surgical procedure, and allowsthe surgeon to more finely position and modify spacer 800 according tothe particular parameters of the patient and the surgical procedure.

Although it is preferable that a port coinciding with a surface of thespacer be of a cylindrical nature having an axis normal to such surface,it is contemplated that any interface herein described can be offsetfrom an axis normal to such surface. For example, a port located on achamfered surface may be normal to any of the front, rear, or sidesurfaces. This would allow for a configuration of spacer 400, forexample, where two or three of the ports accessible from rear end 495are oriented in an on-axis manner.

The present invention has been described with respect to variousembodiments. Nevertheless, it is to be understood that variousmodifications may be made without departing from the spirit and scope ofthe invention. All equivalents are deemed to fall within the scope ofthis description of the invention.

1. A method of inserting and positioning a prosthetic intervertebralspacer in the intervertebral disc space between two adjacent vertebrae,the method comprising the steps of: providing a spacer including alongitudinal axis, an on-axis interface, and an off-axis interface, theon-axis interface being coincident with or parallel to the longitudinalaxis, and the off-axis interface being angled with respect to thelongitudinal axis; engaging a tool to the on-axis interface; insertingthe spacer at least partially into the intervertebral disc space bymoving the tool substantially along an insertion direction; engaging thetool to the off-axis interface; inserting the spacer further into theintervertebral disc space by moving the tool substantially along theinsertion direction, such that the longitudinal axis of the spacer isangled with respect to the insertion direction; and modifying the shapeof the spacer by expanding the spacer.